Organic Solvents for Determination of Bacterial Endotoxin Index in Water-Insoluble Pharmaceutical Substances
Abstract
Substances for manufacture of parenteral drugs require control by the «Bacterial Endotoxin» (BE) Index with the LAL-test. The aim of the study was to show possible applicability of organic solvents in BE determination by the gel-thromb test in case of water-insoluble pharmaceutical substances. The results confirmed that ethyl alcohol practically had no effect on the endotoxin activity. In the routine assays it is advisable to test solutions of the substances at the alcohol concentration of 6% below.
About the Authors
O. V. Shapovalova
Scientific Centre for Expertise of Medical Application Products
Russian Federation
Russian Federation
G. V. Dolgova
Scientific Centre for Expertise of Medical Application Products
Russian Federation
Russian Federation
N. P. Neugodova
Scientific Centre for Expertise of Medical Application Products
Russian Federation
Russian Federation
G. A. Sapozhnikova
Scientific Centre for Expertise of Medical Application Products
Russian Federation
Russian Federation
References
1. Сертификат на реактивы фирмы Associates of CAPE COD, Inc.
2. Государственная фармакопея Российской Федерации, ГФ XII, 1: 128-136.
3. Тутнова А.Д., Демидова В.В., Шаповалова О.В., Долгова Г.В. ЛАЛ-тест. М.: 2007; 4-19
Review
For citations:
Shapovalova O.V., Dolgova G.V., Neugodova N.P., Sapozhnikova G.A. Organic Solvents for Determination of Bacterial Endotoxin Index in Water-Insoluble Pharmaceutical Substances. Antibiot Khimioter = Antibiotics and Chemotherapy. 2013;58(9-10):41-44. (In Russ.)
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